Body Warming in Improving Blood Flow and Oxygen Delivery to Tumors in Patients With Cancer

NCT01896778 | Completed DMC

• 2 other identifiers: I 229812NCI-2013-01198
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

Brief Summary

This randomized pilot clinical trial studies body warming in improving blood flow and oxygen delivery to tumors in patients with cancer. Heating tumor cells to several degrees above normal body temperature may kill tumor cells.

Conditions

Adult Liver Carcinoma; Breast Carcinoma; Colon Carcinoma; Kidney Neoplasm; Lung Carcinoma; Malignant Head and Neck Neoplasm; Malignant Neoplasm; Melanoma; Ovarian Neoplasm; Soft Tissue Sarcoma

Outcome Measures

Primary Outcomes (1)

• Changes in tumor vascular (blood flow, blood volume)

  The primary analysis will be implemented using an analysis-of-covariance model for both blood flow and blood volume.

  Baseline to 24-88 hours

Secondary Outcomes (2)

• Changes in tumor vascular measures

  Baseline to 88-264 hours

• Incidence of adverse events graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0

  Up to 30 days post-treatment

Study Arms (2)

Arm I (B-WARM for 30 minutes)

EXPERIMENTAL

Patients undergo B-WARM at 39 degrees C for 30 minutes.

Procedure: Hyperthermia Treatment; Other: Laboratory Biomarker Analysis

Arm II (B-WARM for 2 hours)

EXPERIMENTAL

Patients undergo B-WARM at 39 degrees C for 2 hours.

Procedure: Hyperthermia Treatment; Other: Laboratory Biomarker Analysis

Interventions

Hyperthermia Treatment PROCEDURE

Undergo B-WARM

Also known as: Clinical Hyperthermia, Diathermy, Hyperthermia, Hyperthermia Therapy

Arm I (B-WARM for 30 minutes); Arm II (B-WARM for 2 hours)

Laboratory Biomarker Analysis OTHER

Correlative studies

Arm I (B-WARM for 30 minutes); Arm II (B-WARM for 2 hours)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with a variety of malignancies (i.e., melanoma, sarcoma, colon, head and neck, renal, breast, lung, ovary, liver)
• Patients must have measurable disease (1.0 cm or greater) by computed tomography (CT) scan
• Have an estimated glomerular filtration rate (eGFR) (using the Cockcroft-Gault equation) of more than 60 mL/min
• Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
• Patients of child-bearing potential must agree to use acceptable contraceptive methods (e.g., double barrier) during treatment
• Patient or legal representative must understand the investigational nature of this study and sign an Independent Ethics Committee/Institutional Review Board approved written informed consent form prior to receiving any study related procedure

You may not qualify if:

• History of prior myocardial infarction or arrhythmia
• History of any condition deemed by the principal investigator to be a contraindication to B-WARM therapy (e.g., skin reaction, dysregulation of thermoregulation, etc)
• All patients with transdermal patches (e.g.; fentanyl, Lidoderm, scopolamine, etc)
• Pregnant or nursing female patients
• Unwilling or unable to follow protocol requirements
• Any condition which in the investigator's opinion deems the patient an unsuitable candidate to receive B-WARM
• Received an investigational agent within 30 days prior to enrollment
• Received any systemic therapy within 21 days prior to planned B-WARM therapy
• Patients may be enrolled on study but at least 21 days should elapse prior to date of B-WARM therapy
• Patients should not have either CT scanning or B-WARM if they have a fever at the time
• Fever should be worked up and treated as appropriate
• Patients should be afebrile for 24 hours prior to scanning or B-WARM therapy

Sponsors & Collaborators

• Roswell Park Cancer Institute: lead

Study Sites (1)

Roswell Park Cancer Institute

Buffalo, New York, 14263, United States

Location

MeSH Terms

Conditions

Carcinoma, Hepatocellular; Breast Neoplasms; Colonic Neoplasms; Kidney Neoplasms; Lung Neoplasms; Head and Neck Neoplasms; Neoplasms; Melanoma; Ovarian Neoplasms; Sarcoma

Interventions

Diathermy

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Urologic Neoplasms; Urogenital Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Diseases; Respiratory Tract Diseases; Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Endocrine Gland Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Genital Neoplasms, Female; Genital Diseases; Endocrine System Diseases; Gonadal Disorders; Neoplasms, Connective and Soft Tissue

Intervention Hierarchy (Ancestors)

Hyperthermia, Induced; Therapeutics

Study Officials

• Anurag Singh

  Roswell Park Cancer Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 8, 2013
• First Posted: July 11, 2013
• Study Start: October 4, 2013
• Primary Completion: February 23, 2018
• Study Completion: February 23, 2018
• Last Updated: July 25, 2022

Record last verified: 2022-07

Locations

US (1)